Healthy VolunteersPhase 1NCT04680273

Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential

A Phase 1 study testing [14C]-GDC-9545, GDC-9545 Solution for Infusion and GDC-9545/F12 Capsule in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: [14C]-GDC-9545, GDC-9545 Solution for Infusion and GDC-9545/F12 Capsule
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited Kingdom
Study dates: 7 Jan 2021to 12 Apr 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy female subjects of non-childbearing potential that are non-pregnant, non-lactating females, who are either postmenopausal or surgically sterile, aged 30 to 65 years, inclusive, at time of signing the Informed Consent Form (ICF)
A body mass index (BMI) between 18.5 and 32.0 kg/m^2, inclusive, at screening
Ability to comply with the study protocol
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day) (Part 1 only)

Who cannot join

Women of childbearing potential, women who are pregnant or breastfeeding
Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 90 days prior to Day 1 (Part 1) or Day 1 of Period 1 (Part 2)
History of serious adverse reaction or serious hypersensitivity to any drug or allergy to the study drug formulation excipients
Subjects who are, or are immediate family members of, a study site or Sponsor employee
Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2.
Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; i.e., the virus that causes COVID-19) infection

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Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at screening
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption >14 units per week
A confirmed positive alcohol breath test at screening or admission
Current smokers and those who have smoked within the last 12 months
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Confirmed positive drugs of abuse test result at screening or admission
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study (Part 1 only)
Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the Investigator or delegate at screening
Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the Investigator
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <70 mL/min using the Cockcroft-Gault equation
History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease (especially peptic ulceration, GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome), neurological or psychiatric disorder, as judged by the Investigator
Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator
Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
Subjects who are taking, or have taken, any medication (e.g., prescription drugs, over-the-counter drugs, hormone replacement therapy [HRT], vaccines, topical medications, herbal or homeopathic remedies, nutritional supplements), other than up to 4 g of paracetamol per day, in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the Investigator.
Subjects who are taking, or have taken, oral antibiotics within 4 weeks or IV antibiotics within 8 weeks prior to admission
Subjects who are taking, or have taken, any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to admission
History of GI surgery (with the exception of appendectomy unless it was performed within the previous 12 months) (Part 1 only)
Acute diarrhea or constipation in the 7 days before the predicted Day 1. If screening occurs >7 days before the Day 1, this criterion will be determined on Day 1. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels for 3 days (Part 1 only)
Malabsorption syndrome or other condition that would interfere with enteral absorption
History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion, including complete left bundle branch block, second- or third-degree atrioventricular heart block, or evidence of prior myocardial infarction
QT interval corrected through use of Fridericia's formula (QTcF) >440 msec demonstrated by at least two ECGs >30 minutes apart
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
Confirmed (e.g., 2 consecutive measurements) baseline heart rate ≤50 bpm prior to enrollment
Current treatment with medications that are well known to prolong the QT interval
Absolute neutrophil count <1.3 x 10^9/L (1300/μL)
Failure to satisfy the Investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase I, Single Center, Open-Label, Partially Randomized, Two Part Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute Bioavailability of Oral Capsule Formulations of GDC-9545 F12 and F18 and the Relative Bioavailability of F18 Compared to F12 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential

This is an open-label, single-center, two part study in healthy female subjects of non-childbearing potential to investigate the absorption, metabolism, and excretion of [14C]-GDC-9545 (Part 1), the absolute bioavailability of formulations F12 and F18 (i.e., GDC-9545/F12 capsule, 30 mg and GDC-9545/F18 capsule, 30 mg) and relative bioavailability of GDC-9545 oral capsule F18 to the F12 formulation (Part 2). It is planned that Part 1 will begin prior to Part 2 of the study, and that the two parts of the study will partially overlap.

Conditions: Healthy Volunteers
Being tested: [14C]-GDC-9545, GDC-9545 Solution for Infusion, GDC-9545/F12 Capsule, GDC-9545/F18 Capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]-GDC-9545Drug
Also called Giredestrant, RO7197597, RG6171
Participants will receive a single oral dose of [14C]-GDC-9545 capsule, 30 milligrams (mg) (not more than [NMT] 4.6 megabecquerel [MBq]; 124 microcurie [μCi]) with approximately 240 millilitres (mL) water in the fasted state.
GDC-9545 Solution for InfusionDrug
Also called Giredestrant, RO7197597, RG6171
Treatment B: 30 mg GDC-9545 as a solution for infusion, 3 mg/mL administered intravenously (IV) in 10 mL as an infusion over 30 minutes.
GDC-9545/F12 CapsuleDrug
Also called Giredestrant, RO7197597, RG6171
Treatment C: GDC-9545/F12 capsule, 30 mg, administered orally with approximately 240 mL water.
GDC-9545/F18 CapsuleDrug
Also called Giredestrant, RO7197597, RG6171
Treatment D: GDC-9545/F18 capsule, 30 mg, administered orally with approximately 240 mL water.

Study groups in NCT04680273
Study group	Role	What they receive
Part 1: [14C]-GDC-9545	Experimental	Participants will be enrolled to receive a single dose of Carbon-14 labelled [14C]-GDC-9545. Receives: Drug: [14C]-GDC-9545
Part 2: GDC-9545 Treatment Sequence BCD	Experimental	Participants will be randomly allocated to one of two treatment sequences (BCD for this arm). In each treatment period, participants will receive a single dose of GDC-9545 in the fasted state in each of three treatment periods. The three treatment periods will be separated by a treatment-free washout between each study drug administration. Receives: Drug: GDC-9545 Solution for Infusion; Drug: GDC-9545/F12 Capsule; Drug: GDC-9545/F18 Capsule
Part 2: GDC-9545 Treatment Sequence BDC	Experimental	Participants will be randomly allocated to one of two treatment sequences (BDC for this arm). In each treatment period, participants will receive a single dose of GDC-9545 in the fasted state in each of three treatment periods. The three treatment periods will be separated by a treatment-free washout between each study drug administration. Receives: Drug: GDC-9545 Solution for Infusion; Drug: GDC-9545/F12 Capsule; Drug: GDC-9545/F18 Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: From Day 1 to Day 42 (0-1008 hours)
Part 1: Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: From Day 1 to Day 42 (0-1008 hours)
Part 1: Mean Amount of Total Radioactivity (Ae) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Collection Interval
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: 0-12, 12-24, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384, 384-408, 408-432, 432-456, 456-480, 480-648, 648-672, 672-816, 816-840, 840-984, & 984-1008 hours
Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Cumulative Collection Interval
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: 0-24, 0-48, 0-72, 0-96, 0-120, 0-144, 0-168, 0-192, 0-216, 0-240, 0-264, 0-288, 0-312, 0-336, 0-360, 0-384, 0-408, 0-432, 0-456, 0-480, 0-648, 0-672, 0-816, 0-840, 0-984, and 0-1008 hours
Part 1: Mean Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (Fe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) by Collection Interval
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: 0-12, 12-24, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384, 384-408, 408-432, 432-456, 456-480, 480-648, 648-672, 672-816, 816-840, 840-984, & 984-1008 hours
Part 1: Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) by Cumulative Collection Interval
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Measured: 0-24, 0-48, 0-72, 0-96, 0-120, 0-144, 0-168, 0-192, 0-216, 0-240, 0-264, 0-288, 0-312, 0-336, 0-360, 0-384, 0-408, 0-432, 0-456, 0-480, 0-648, 0-672, 0-816, 0-840, 0-984, and 0-1008 hours
Part 1: Maximum Observed Concentration (Cmax), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The unit of measure for the total radioactivity concentrations is nanogram equivalent of free drug per millilitre.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Time to Maximum Observed Concentration (Tmax), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Area Under the Concentration-Time Curve From Time 0 to 72 Hours [AUC(0-72)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and post-dose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours
Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Measurable Concentration [AUC(0-t)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Terminal Elimination Half-Life (t1/2), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: First Order Rate Constant Associated With Terminal Portion of the Curve (λz), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Total Body Clearance Calculated After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (CL/F), Estimated for GDC-9545 in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Apparent Volume of Distribution Where Fraction of Dose Bioavailable is Unknown (Vz/F), Estimated for GDC-9545 in Plasma
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Measured: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Part 1: Total Radioactivity Concentrations of [14C]-GDC-9545 in Plasma and Whole Blood at Specified Timepoints
Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. For calculation of the geometric mean, values reported as not detectable have been set to 0.5× the limit of detection (LOD); the LOD was 11.0 nanogram equivalent of free drug per millilitre (mL).
Measured: Postdose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours
Part 1: Whole Blood to Plasma Total Radioactivity Concentration Ratios of [14C]-GDC-9545 at Specified Timepoints
Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The limit of detection was 11.0 nanogram equivalent of free drug per millilitre (mL).
Measured: Postdose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours
Part 2: Absolute Bioavailability (F) of GDC-9545/F12 and /F18 Capsules Calculated Relative to GDC-9545 Solution for Infusion Based on the Adjusted AUC(0-∞), Estimated in Plasma Samples
Absolute bioavailability of the GDC-9545/F12 and /F18 capsules were calculated relative to GDC-9545 solution for infusion based on the adjusted geometric mean AUC(0-∞) values obtained after oral and intravenous (IV) administration of GDC-9545. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment and sequence fitted as fixed effects and subject within sequence fitted as a random effect.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Relative Bioavailability Based on the Adjusted Cmax (Frel Cmax) of the GDC-9545/F18 Capsule Calculated Relative to the GDC-9545/F12 Capsule, Estimated in Plasma Samples
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean Cmax values. Log-transformed Cmax was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Relative Bioavailability Based on the Adjusted AUC(0-∞) [Frel AUC(0-∞)] of the GDC-9545/F18 Capsule Calculated Relative to the GDC-9545/F12 Capsule, Estimated in Plasma Samples
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-∞) values. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Relative Bioavailability Based on the Adjusted AUC(0-t) [Frel AUC(0-t)] of GDC-9545/F18 Capsule Calculated Relative to GDC-9545/F12 Capsule, Estimated in Plasma Samples
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-t) values. Log-transformed AUC(0-t) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8

Secondary outcomes (14)

Part 2: Cmax for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Tmax for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: AUC(0-t) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: AUC(0-∞) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: t1/2 for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: First Order Rate Constant Associated With Terminal Portion of the Curve (λz) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Total Body Clearance (CL) After a Single IV Administration for GDC-9545 Solution for Infusion, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Total Body Clearance Calculated After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (CL/F) for GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Volume of Distribution Based on the Terminal Phase Calculated Using AUC(0-∞) After a Single IV Administration (Vz) for GDC-9545 Solution for Infusion, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Apparent Volume of Distribution Based on the Terminal Phase Calculated With AUC(0-∞) After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (Vz/F) for GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry.
Measured: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Parts 1 and 2: Number of Participants With at Least One Adverse Event, With Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. AEs of special interest were: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Cases of potential drug-induced kidney injury; Grade ≥3 nausea/vomiting/diarrhea; Grade ≥2 thromboembolic events; Grade ≥3 renal failure; Grade ≥3 hepatitis or elevation in ALT or AST; Grade ≥2 vaginal or uterine hemorrhage; Grade ≥2 bradycardia; Any grade of endometrial cancer; and, Suspected transmission of an infectious agent by the study drug.
Measured: From Baseline until end of study (up to 42 days and 35 days for Parts 1 and 2, respectively)
Parts 1 and 2: Number of Participants With at Least One Abnormality in Laboratory Safety Tests, Reported as Adverse Events
Participants provided blood samples at the specified timepoints for laboratory analysis of clinical chemistry, hematology, and coagulation panels (please refer to Appendices 1 and 2 of the protocol for a complete list). Any of the laboratory test results that were outside of a parameter's normal reference range were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Measured: Part 1: Baseline and Discharge Day (up to 21 days); Part 2: Baseline, Day -1 of each of the 3 treatment periods, and Discharge Day (up to 29 days)
Parts 1 and 2: Number of Participants With at Least One Abnormality in Vital Sign Measurements, Reported as Adverse Events
Vital sign measurements included pulse rate, systolic and diastolic blood pressure while the participant was in a supine position for 5 minutes, and oral temperature. Any of the vital sign results that were outside of a parameter's normal range were considered abnormalities. Not every vital sign abnormality qualified as an adverse event (AE). A vital sign result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Measured: Part 1: Baseline, predose and 1, 4, and 24 hours postdose, and Discharge Day (up to 21 days); Part 2: Baseline, predose and 0.5, 1, 4, and 24 hours postdose for each of the 3 treatment periods, and Discharge Day (up to 29 days)
Parts 1 and 2: Number of Participants With at Least One Abnormality in 12-Lead Electrocardiogram Measurements, Reported as Adverse Events
The 12-lead electrocardiograms (ECG) recorded measurements of heart rate, and PR, RR, QRS, uncorrected QT, and QTcF intervals. Any of the ECG parameter results that were outside of the normal range were considered abnormalities. Not every ECG abnormality qualified as an adverse event (AE). An ECG result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Measured: Part 1: Baseline (Day 1, predose), 1, 4, and 24 hours postdose, and Discharge Day (up to 21 days); Part 2: Baseline (Day 1, predose), 0.5, 1, 4, and 24 hours postdose for each of the 3 treatment periods, and Discharge Day (up to 29 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 202112 Apr 2021

First posted22 Dec 2020
Study start7 Jan 2021
Primary completion12 Apr 2021
Study completion12 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04680273
Sponsor's protocol ID: GP42662
Other IDs: 2020-004650-29
Status last verified: Jan 2023
First submitted: 17 Dec 2020
Last updated: 2 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single Center, Open-Label, Partially Randomized, Two Part Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute Bioavailability of Oral Capsule Formulations of GDC-9545 F12 and F18 and the Relative Bioavailability of F18 Compared to F12 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential
ClinicalTrials.gov ID: NCT04680273
Acronym / sponsor ID: GP42662
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 7 Jan 2021 (actual)
Primary completion: 12 Apr 2021 (actual)
Study completion: 12 Apr 2021 (actual)
First posted: 22 Dec 2020 (actual)
Results: Posted 2 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1: [14C]-GDC-9545	Experimental	Drug: [14C]-GDC-9545Participants will be enrolled to receive a single dose of Carbon-14 labelled [14C]-GDC-9545.
Part 2: GDC-9545 Treatment Sequence BCD	Experimental	Drug: GDC-9545 Solution for Infusion, Drug: GDC-9545/F12 Capsule, Drug: GDC-9545/F18 CapsuleParticipants will be randomly allocated to one of two treatment sequences (BCD for this arm). In each treatment period, participants will receive a single dose of GDC-9545 in the fasted state in each of three treatment periods. The three treatment periods will be separated by a treatment-free washout between each study drug administration.
Part 2: GDC-9545 Treatment Sequence BDC	Experimental	Drug: GDC-9545 Solution for Infusion, Drug: GDC-9545/F12 Capsule, Drug: GDC-9545/F18 CapsuleParticipants will be randomly allocated to one of two treatment sequences (BDC for this arm). In each treatment period, participants will receive a single dose of GDC-9545 in the fasted state in each of three treatment periods. The three treatment periods will be separated by a treatment-free washout between each study drug administration.

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy female subjects of non-childbearing potential that are non-pregnant, non-lactating females, who are either postmenopausal or surgically sterile, aged 30 to 65 years, inclusive, at time of signing the Informed Consent Form (ICF)
A body mass index (BMI) between 18.5 and 32.0 kg/m^2, inclusive, at screening
Ability to comply with the study protocol
Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day) (Part 1 only)

Key exclusion criteria (33 listed)

Women of childbearing potential, women who are pregnant or breastfeeding
Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 90 days prior to Day 1 (Part 1) or Day 1 of Period 1 (Part 2)
History of serious adverse reaction or serious hypersensitivity to any drug or allergy to the study drug formulation excipients
Subjects who are, or are immediate family members of, a study site or Sponsor employee
Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C]-GDC-9545Also: Giredestrant, RO7197597, RG6171Participants will receive a single oral dose of [14C]-GDC-9545 capsule, 30 milligrams (mg) (not more than [NMT] 4.6 megabecquerel [MBq]; 124 microcurie [μCi]) with approximately 240 millilitres (mL) water in the fasted state.	Drug	Part 1: [14C]-GDC-9545
GDC-9545 Solution for InfusionAlso: Giredestrant, RO7197597, RG6171Treatment B: 30 mg GDC-9545 as a solution for infusion, 3 mg/mL administered intravenously (IV) in 10 mL as an infusion over 30 minutes.	Drug	Part 2: GDC-9545 Treatment Sequence BCD, Part 2: GDC-9545 Treatment Sequence BDC
GDC-9545/F12 CapsuleAlso: Giredestrant, RO7197597, RG6171Treatment C: GDC-9545/F12 capsule, 30 mg, administered orally with approximately 240 mL water.	Drug	Part 2: GDC-9545 Treatment Sequence BCD, Part 2: GDC-9545 Treatment Sequence BDC
GDC-9545/F18 CapsuleAlso: Giredestrant, RO7197597, RG6171Treatment D: GDC-9545/F18 capsule, 30 mg, administered orally with approximately 240 mL water.	Drug	Part 2: GDC-9545 Treatment Sequence BCD, Part 2: GDC-9545 Treatment Sequence BDC

Primary outcome

Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Time frame: From Day 1 to Day 42 (0-1008 hours)
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period
Time frame: From Day 1 to Day 42 (0-1008 hours)
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Mean Amount of Total Radioactivity (Ae) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Collection Interval
Time frame: 0-12, 12-24, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384, 384-408, 408-432, 432-456, 456-480, 480-648, 648-672, 672-816, 816-840, 840-984, & 984-1008 hours
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Cumulative Collection Interval
Time frame: 0-24, 0-48, 0-72, 0-96, 0-120, 0-144, 0-168, 0-192, 0-216, 0-240, 0-264, 0-288, 0-312, 0-336, 0-360, 0-384, 0-408, 0-432, 0-456, 0-480, 0-648, 0-672, 0-816, 0-840, 0-984, and 0-1008 hours
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Mean Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (Fe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) by Collection Interval
Time frame: 0-12, 12-24, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384, 384-408, 408-432, 432-456, 456-480, 480-648, 648-672, 672-816, 816-840, 840-984, & 984-1008 hours
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) by Cumulative Collection Interval
Time frame: 0-24, 0-48, 0-72, 0-96, 0-120, 0-144, 0-168, 0-192, 0-216, 0-240, 0-264, 0-288, 0-312, 0-336, 0-360, 0-384, 0-408, 0-432, 0-456, 0-480, 0-648, 0-672, 0-816, 0-840, 0-984, and 0-1008 hours
Following a single oral dose of 30 milligrams of [14C]-GDC-9545, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting. The lower limits of detection in urine and fecal samples were 0.423 and 8.36 nanogram equivalent of free drug per gram of sample, respectively. Following Day 21 (480 hours), where urine/fecal collections were no longer continuous and spot sampling days commenced, interpolation of Ae was calculated to estimate the amount excreted on non-collection days (collection intervals with interpolated values included 480-648 hours, 672-816 hours, and 840-984 hours).
Part 1: Maximum Observed Concentration (Cmax), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The unit of measure for the total radioactivity concentrations is nanogram equivalent of free drug per millilitre.
Part 1: Time to Maximum Observed Concentration (Tmax), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Area Under the Concentration-Time Curve From Time 0 to 72 Hours [AUC(0-72)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and post-dose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Measurable Concentration [AUC(0-t)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)], Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Terminal Elimination Half-Life (t1/2), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity (TR) concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: First Order Rate Constant Associated With Terminal Portion of the Curve (λz), Estimated for GDC-9545 in Plasma and for Total Radioactivity in Plasma and Whole Blood
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Total Body Clearance Calculated After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (CL/F), Estimated for GDC-9545 in Plasma
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Apparent Volume of Distribution Where Fraction of Dose Bioavailable is Unknown (Vz/F), Estimated for GDC-9545 in Plasma
Time frame: Pre-dose and 1, 1.5, 2, 2.5, 3, 5, 6, 8, and 12 hours post-dose on Day 1, daily from Day 2 to Day 21, and Days 28, 35, and 42
Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of GDC-9545 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.
Part 1: Total Radioactivity Concentrations of [14C]-GDC-9545 in Plasma and Whole Blood at Specified Timepoints
Time frame: Postdose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours
Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. For calculation of the geometric mean, values reported as not detectable have been set to 0.5× the limit of detection (LOD); the LOD was 11.0 nanogram equivalent of free drug per millilitre (mL).
Part 1: Whole Blood to Plasma Total Radioactivity Concentration Ratios of [14C]-GDC-9545 at Specified Timepoints
Time frame: Postdose at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours
Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting. The limit of detection was 11.0 nanogram equivalent of free drug per millilitre (mL).
Part 2: Absolute Bioavailability (F) of GDC-9545/F12 and /F18 Capsules Calculated Relative to GDC-9545 Solution for Infusion Based on the Adjusted AUC(0-∞), Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Absolute bioavailability of the GDC-9545/F12 and /F18 capsules were calculated relative to GDC-9545 solution for infusion based on the adjusted geometric mean AUC(0-∞) values obtained after oral and intravenous (IV) administration of GDC-9545. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment and sequence fitted as fixed effects and subject within sequence fitted as a random effect.
Part 2: Relative Bioavailability Based on the Adjusted Cmax (Frel Cmax) of the GDC-9545/F18 Capsule Calculated Relative to the GDC-9545/F12 Capsule, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean Cmax values. Log-transformed Cmax was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.
Part 2: Relative Bioavailability Based on the Adjusted AUC(0-∞) [Frel AUC(0-∞)] of the GDC-9545/F18 Capsule Calculated Relative to the GDC-9545/F12 Capsule, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-∞) values. Log-transformed AUC(0-∞) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.
Part 2: Relative Bioavailability Based on the Adjusted AUC(0-t) [Frel AUC(0-t)] of GDC-9545/F18 Capsule Calculated Relative to GDC-9545/F12 Capsule, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Relative bioavailability of the GDC-9545/F18 capsule was calculated relative to the GDC-9545/F12 capsule based on the adjusted geometric mean AUC(0-t) values. Log-transformed AUC(0-t) was analyzed using mixed effects modelling techniques. The model included terms for treatment, sequence, and period fitted as fixed effects and subject nested within sequence as a random effect.

14 secondary outcomes

Part 2: Cmax for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Tmax for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: AUC(0-t) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: AUC(0-∞) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: t1/2 for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: First Order Rate Constant Associated With Terminal Portion of the Curve (λz) for GDC-9545 Solution for Infusion and GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Total Body Clearance (CL) After a Single IV Administration for GDC-9545 Solution for Infusion, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Total Body Clearance Calculated After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (CL/F) for GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Volume of Distribution Based on the Terminal Phase Calculated Using AUC(0-∞) After a Single IV Administration (Vz) for GDC-9545 Solution for Infusion, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Part 2: Apparent Volume of Distribution Based on the Terminal Phase Calculated With AUC(0-∞) After a Single Extravascular Administration Where Fraction of Dose Bioavailable is Unknown (Vz/F) for GDC-9545/F12 and /F18 Capsules, Estimated in Plasma Samples
Time frame: For each treatment period: Pre-dose and 0.25, 0.5, 0.58, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose on Day 1, and daily from Day 2 to Day 8
Parts 1 and 2: Number of Participants With at Least One Adverse Event, With Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: From Baseline until end of study (up to 42 days and 35 days for Parts 1 and 2, respectively)
Parts 1 and 2: Number of Participants With at Least One Abnormality in Laboratory Safety Tests, Reported as Adverse Events
Time frame: Part 1: Baseline and Discharge Day (up to 21 days); Part 2: Baseline, Day -1 of each of the 3 treatment periods, and Discharge Day (up to 29 days)
Parts 1 and 2: Number of Participants With at Least One Abnormality in Vital Sign Measurements, Reported as Adverse Events
Time frame: Part 1: Baseline, predose and 1, 4, and 24 hours postdose, and Discharge Day (up to 21 days); Part 2: Baseline, predose and 0.5, 1, 4, and 24 hours postdose for each of the 3 treatment periods, and Discharge Day (up to 29 days)
Parts 1 and 2: Number of Participants With at Least One Abnormality in 12-Lead Electrocardiogram Measurements, Reported as Adverse Events
Time frame: Part 1: Baseline (Day 1, predose), 1, 4, and 24 hours postdose, and Discharge Day (up to 21 days); Part 2: Baseline (Day 1, predose), 0.5, 1, 4, and 24 hours postdose for each of the 3 treatment periods, and Discharge Day (up to 29 days)

Results and safety

Results posted to the registry on 2 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: [14C]-GDC-9545	6	6
Part 2: GDC-9545 Treatment Sequence BCD	5	5
Part 2: GDC-9545 Treatment Sequence BDC	5	5

Primary outcome: Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period

Time frame: From Day 1 to Day 42 (0-1008 hours). Mean (Standard Deviation). Unit: milligram equivalent of free drug

Measure	Part 1: [14C]-GDC-9545 - Urine n = 6	Part 1: [14C]-GDC-9545 - Feces n = 6	Part 1: [14C]-GDC-9545 - Total (Urine and Feces) n = 6
Value	2.78 (0.503)	20.70 (0.712)	23.50 (0.952)

Primary outcome: Part 1: Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]-GDC-9545 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period

Time frame: From Day 1 to Day 42 (0-1008 hours). Mean (Standard Deviation). Unit: Percentage of radioactive dose

Measure	Part 1: [14C]-GDC-9545 - Urine n = 6	Part 1: [14C]-GDC-9545 - Feces n = 6	Part 1: [14C]-GDC-9545 - Total (Urine and Feces) n = 6
Value	9.039 (1.634)	67.410 (2.313)	77.012 (2.794)

Primary outcome: Part 1: Mean Amount of Total Radioactivity (Ae) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Collection Interval

Time frame: 0-12, 12-24, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384, 384-408, 408-432, 432-456, 456-480, 480-648, 648-672, 672-816, 816-840, 840-984, & 984-1008 hours. Mean (Standard Deviation). Unit: nanogram equivalent of free drug

Measure	Part 1: [14C]-GDC-9545 - Urine n = 6	Part 1: [14C]-GDC-9545 - Feces n = 6	Part 1: [14C]-GDC-9545 - Total (Urine and Feces) n = 6
0-12 hours	668000 (78600)	–	–
12-24 hours	307000 (54300)	–	–
0-24 hours	–	6980 (17100)	982000 (140000)
24-48 hours	410000 (56400)	1980000 (3240000)	2390000 (3250000)
48-72 hours	242000 (50600)	3880000 (4230000)	4120000 (4200000)
72-96 hours	174000 (54800)	5730000 (4420000)	5900000 (4380000)
96-120 hours	129000 (48000)	902000 (746000)	1030000 (761000)
120-144 hours	94100 (41100)	2330000 (2590000)	2420000 (2620000)

Population analysed: Mass Balance Population, Part 1: all participants who received a dose of study drug, had evaluable total radioactivity concentration (urinary and fecal) data, and had no protocol deviations that affected the mass balance analysis (e.g., spillage or missing collections, or vomiting). Only urine samples were collected over 2 intervals in the first 24 hours postdose: 0-12 hours and 12-24 hours; fecal samples were collected over a single 0-24 hours interval.

Primary outcome: Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) by Cumulative Collection Interval

Time frame: 0-24, 0-48, 0-72, 0-96, 0-120, 0-144, 0-168, 0-192, 0-216, 0-240, 0-264, 0-288, 0-312, 0-336, 0-360, 0-384, 0-408, 0-432, 0-456, 0-480, 0-648, 0-672, 0-816, 0-840, 0-984, and 0-1008 hours. Mean (Standard Deviation). Unit: nanogram equivalent of free drug

Measure	Part 1: [14C]-GDC-9545 - Urine n = 6	Part 1: [14C]-GDC-9545 - Feces n = 6	Part 1: [14C]-GDC-9545 - Total (Urine and Feces) n = 6
0-24 hours	975000 (128000)	6980 (17100)	982000 (140000)
0-48 hours	1380000 (175000)	1980000 (3230000)	3370000 (3230000)
0-72 hours	1630000 (215000)	5860000 (4840000)	7490000 (4750000)
0-96 hours	1800000 (262000)	11600000 (5790000)	13400000 (5640000)
0-120 hours	1930000 (299000)	12500000 (5520000)	14400000 (5330000)
0-144 hours	2020000 (334000)	14800000 (3120000)	16800000 (2880000)
0-168 hours	2080000 (352000)	16000000 (2740000)	18100000 (2510000)
0-192 hours	2130000 (370000)	16500000 (2840000)	18600000 (2590000)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline until end of study (up to 42 days and 35 days for Parts 1 and 2, respectively). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: [14C]-GDC-9545	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2: GDC-9545 Solution for Infusion (Treatment B)	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Part 2: GDC-9545/F12 Capsule (Treatment C)	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Part 2: GDC-9545/F18 Capsule (Treatment D)	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Part 2: Overall: Any GDC-9545 (Treatments B, C, or D)	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Genentech, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-GDC-9545, GDC-9545 Solution for Infusion and GDC-9545/F12 Capsule in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]-GDC-9545 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period (time frame: From Day 1 to Day 42 (0-1008 hours)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04680273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.